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Vyleesi Label Protocol (FDA-approved) Parameter Dose Value 1.75 mg Source Vyleesi label / Mayo Clinic drug summary Parameter Route Value Subcutaneous (abdomen or thigh) Source Vyleesi label Parameter Timing Value 45 minutes before sexual activity Source Vyleesi label Parameter Maximum frequency Value 1 dose per 24 hours Source Vyleesi label Parameter Maximum monthly use Value 8 doses per month Source Vyleesi label Parameter Approved population Value Premenopausal women with HSDD Source Vyleesi label Reflects the FDA-approved Vyleesi label as summarized by Mayo Clinic (last updated Feb 2026)

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Patients randomized to exenatide started on a dose of 5 mcg twice-daily for 4 weeks and then were escalated to 10 mcg twice daily

The burden associated with these new requirements is the time and effort required by manufacturers of drugs and biologicals to submit ASP data to CMS quarterly under sections 1847A and 1927 of the Act and prepare and submit the reasonable assumption document and warrantee/certification letter to CMS